Standard Operating Procedure for Maintenance of Analytical Testing Equipment

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance and operation of analytical testing equipment in pharmaceutical manufacturing facilities to ensure accurate and reliable analytical testing processes and data integrity.

2) Scope

This SOP applies to all analytical testing equipment used within the facility premises.

3) Responsibilities

The Quality Control Department is responsible for implementing and adhering to this SOP. The Analytical Testing Technician or designated personnel are responsible for the maintenance and operation of analytical testing equipment.

4) Procedure

1. Preventive Maintenance
   1. Develop a preventive maintenance schedule for analytical testing equipment based on manufacturer recommendations and operational requirements.
   2. Inspect equipment components such as chromatography systems, spectrophotometers, balances, and software interfaces regularly for accuracy, calibration, and cleanliness.
2. Cleaning and Calibration
   1. Follow standard operating procedures for cleaning and calibrating analytical testing equipment to maintain accuracy and prevent contamination.
   2. Use approved cleaning agents and calibration standards suitable for equipment materials and accuracy requirements.
3. Performance Verification
   1. Conduct performance verification tests to ensure analytical testing equipment operates within specified parameters such as accuracy, precision, and detection limits.
   2. Calibrate equipment as per calibration procedures and maintain calibration records.
4. Method Validation and Verification
   1. Perform method validation and verification studies as required for analytical testing methods.
   2. Document validation and verification protocols, results, and any deviations.
5. Documentation and Reporting
   1. Maintain accurate records of equipment inspections, maintenance activities, performance tests, calibrations, method validations, and any adjustments made to the analytical testing equipment.
   2. Document any incidents or deviations from standard operating procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Preventive Maintenance Schedule, Cleaning and Calibration Procedures, Performance Verification Reports, Method Validation and Verification Protocols, Calibration Records

7) Reference, if any

Manufacturer’s recommendations for analytical testing equipment maintenance, industry guidelines for analytical testing processes, regulatory requirements for equipment cleanliness and performance, and local safety regulations.

8) SOP Version

Version 1.0